The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Device Description

The ChemoLock is a needlefree, single-use, Closed System Drug Transfer Device (CSTD). The ChemoLock has a mechanical means to prevent the transfer of environmental contaminants into the system, and the escape of drug or vapor concentrations outside the system. The system includes closed vial and bag access devices, a closed syringe adapter and closed patient administration sets. All components of the system include passive self-sealing mechanisms which cannot be deactivated and remain protective through disposal.

AI/ML Overview

The provided document describes the ChemoLock Closed System Drug Transfer Device (K131549). Here's an analysis of its acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with numerical targets. Instead, it describes functional performance goals. Based on the "Intended Use" and "Non Clinical Performance Data Summary" sections, here's a representation of the acceptance criteria and the device's reported performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance
Prevent transfer of environmental contaminants (bacterial and airborne) into the system.	"Microbial Ingress testing..." shows that the "ChemoLock Closed System Drug Transfer Device has the ability to prevent bacterial ingress... completely if used in accordance with the directions for use."
Prevent escape of drug or vapor concentrations outside the system.	"The Evaluation of Closed-system Drug Transfer Devices..." shows that the "ChemoLock Closed System Drug Transfer Device is able to prevent the egress of chemicals both during preparation and transfer of the cytotoxic agent. Results... suggest that the ChemoLock system was effective in preventing detectible surface contamination during three separate trials of compounding activities with known amounts of cyclophosphamide."
Be needle-free.	"The ChemoLock is needlefree..." (Feature comparison table also states "NeedleFree").
Cannot be deactivated (passively aid in preventing needlestick injuries and exposure).	"The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel."
Prevent leakage of fluid when in the inactivated state.	"The ChemoLock and Port will prevent leakage of fluid when in the inactivated state."
Self-seal and offer a dry, leak-proof disconnection when disconnected.	"When disconnected, the ChemoLock and Port will self-seal and offer a dry, leak proof disconnection."
Equalize Vial Pressure when Accessed.	Listed as "Yes" and "Identical to K123213 and K081361" in the feature comparison table.
Act as a Microbial Barrier.	Listed as "Yes" and "Identical to K081361 and K082806" in the feature comparison table.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "three separate trials" for the chemical egress testing. However, it does not specify the sample size (e.g., number of devices, number of repetitions) used within each trial or for the microbial ingress testing.
Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, so the testing would likely have been conducted by or for ICU Medical, Inc., based in Salt Lake City, UT, USA. The studies are non-clinical performance data, implying they are laboratory or bench tests rather than studies involving human subjects (prospective or retrospective clinical studies).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the studies described are non-clinical (laboratory/bench testing) and do not involve human diagnostic interpretation or ground truth established by medical experts in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical (laboratory/bench testing) and do not involve human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The ChemoLock is a Closed System Drug Transfer Device, a physical medical device for drug preparation and administration, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The ChemoLock is a physical medical device, not an algorithm or software-only device. The described performance studies are for the physical device itself.

7. Type of Ground Truth Used

For the non-clinical performance studies:

Microbial Ingress: The implicit ground truth would be the absence of bacterial growth after exposure to a bacterial challenge. This is determined by standard microbiological testing methods.
Chemical/Vapor Egress: The implicit ground truth would be the absence of detectable chemical contamination (specifically cyclophosphamide) on surfaces. This is determined by analytical chemistry methods (e.g., chromatography, spectroscopy) that can detect the target chemical.

8. Sample Size for the Training Set

This information is not applicable. The ChemoLock is a physical medical device and does not involve AI or machine learning models that require a "training set." The testing described is performance verification for the physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for a physical medical device like the ChemoLock.

Summary

{0}------------------------------------------------

K131549

JUL 2 6 2013

Section 5 510(k) Summary

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

Company Name:	ICU Medical, Inc.4455 Atherton Drive
Address:	Salt Lake City, UT 84123
Contact Person:	Katherine KennerRegulatory Affairs SpecialistICU Medical, Inc.Phone: (801) 264 1702Fax: (801) 264 1755
Preparation Date:	May 28, 2013
Device (Trade Name):	ChemoLock Closed System Drug Transfer Device
Common/Usual Name:	Closed System Drug Transfer Device
Classification Names:	21 CFR 880.5440. Closed System Drug Transfer Device. Product Code:800NB and 80FPA.
Predicate Device:	K123213 BD Phaseal Closed System Drug Transfer DeviceK081361 ChemoClave Cytotoxic Medication Preparation and DeliverySystemK082806 Spinning Spiros
Device Description:	The ChemoLock is a needlefree, single-use, Closed System Drug TransferDevice (CSTD). The ChemoLock has a mechanical means to prevent thetransfer of environmental contaminants into the system, and the escape ofdrug or vapor concentrations outside the system. The system includesclosed vial and bag access devices, a closed syringe adapter and closedpatient administration sets. All components of the system include passiveself-sealing mechanisms which cannot be deactivated and remainprotective through disposal.
Intended Use:	The ChemoLock Closed System Drug Transfer Device prevents thetransfer of environmental contaminants, including bacterial and airbornecontaminants into the system, and the escape of drug or vaporconcentrations outside the system. The ChemoLock is needlefree andcannot be deactivated, which will passively aid in preventing needlestickinjuries and the exposure to cytotoxic medications for healthcarepersonnel.
Technology:	The ChemoLock Closed System Drug Transfer Device employs the samefundamental scientific technology as its predicate devices. Please seeTable 1 for more information.

Feature	ChemoClave	Spinning Spiros	Phaseal	ChemoLock	Comparison
510KNUMBER	K081361	K082806	K123213	K131549	N/A
EqualizesVial PressurewhenAccessed	Yes	Not Applicable	Yes	Yes	Identical toK123213 andK081361
Feature	ChemoClave	Spinning Spiros	Phaseal	ChemoLock	Comparison
PreventsEscape ofDrug orVaporConcentratio	Yes	Yes	Yes	Yes	Identical
Closed DrugTransferMechanism	Elastomericsingle membrane(ISO)	Elastomericdoublemembrane (ISO)	Elastomericdoublemembrane (non-ISO)	Elastomericdoublemembrane (non-ISO)	Identical toK123213
ActivationMechanism	ISO Luer locking	ISO Luer Locking	Non-ISO push-togetherconnection withbayonet lock	Non-ISO push-togetherconnection withclip locks	Similar toK123213
AvailableAccessoriesand UseableComponents	Vial Access, BagAccess, SyringeAdapter andPatientAdministrationSets	Syringe Adapterand PatientAdministrationSets	Vial Access, BagAccess, SyringeAdapter, InjectionPort Adapter	Vial Access, BagAccess, SyringeAdapter andPatientAdministrationSets	Identical toK081361
NeedleFree	NeedleFree	NeedleFree	No, 18G needlewith safety sleeveand/or steel spike	NeedleFree	Identical toK081361 andK082806
Connectionto ExternalEquipment	Standard ISO luerconnection	Standard ISO Luerconnection withpermanentlocking featurewhich preventsremoval and staysprotectivethrough disposal	Standard ISO LuerConnections andVial Spikes	Standard ISO luerconnection withpermanentlocking featurewhich preventsremoval and staysprotectivethrough disposal	Identical toK082806
MicrobialBarrier	Yes	Yes	Yes for VialAccessNo for SyringeAdapter	Yes	Identical toK081361 andK082806
Sterilization	Ebeam	Ebeam	EO	Ebeam	Identical toK081361 andK082806
Materials ofConstruction	Biocompatiblethermoplasticsand silicone	Biocompatiblethermoplasticsand silicone	Biocompatiblethermoplastics,silicone andstainless steel	Biocompatiblethermoplasticsand silicone	Identical toK081361 andK082806
Single Use	Yes	Yes	Yes	Yes	Identical

Table 1: Summary Comparison of Technological Characteristics Table

{1}------------------------------------------------

・

•

{2}------------------------------------------------

Determination of Substantial Equivalence:

Non Clinical Performance Data Summary The demonstration of substantial equivalence is based on a comparison of features to the predicate devices and an assessment of non-clinical performance data. Information is included with this 510(k) submission that supports this determination.

The ChemoLock Closed System Drug Transfer Device is intended to be used with closed vial and bag access devices, closed syringe adapters, and closed patient administration sets. The two piece system, comprised of two components called the ChemoLock and the ChemoLock Port (or Port), is intended to allow the user to adapt an ISO-594 luer system to a custom adapted, Closed System Drug Transfer Device. The female luer end of the ChemoLock is compatible with all male 150 connections and the other side is only compatible with the Port. The male end of the Port is compatible with all female ISO connections while the other side is only compatible with the ChemoLock.

The ChemoLock and Port will prevent leakage of fluid when in the inactivated state. When the ChemoLock is connected to the Port, the fluid path is activated and becomes an onen two way conduit. When disconnected, the ChemoLock and Port will self-seal and offer a dry, leak proof disconnection.

Microbial Ingress testing as provided in this submission shows that the ChemoLock Closed System Drug Transfer Device has the ability to prevent bacterial ingress. Said testing shows that the device will prevent bacterial ingress completely if used in accordance with the directions for use. The prevention of bacterial ingress is specifically important for pediatrics and immune-compromised patients that would otherwise be at risk of infections.

The Evaluation of Closed-system Drug Transfer Devices as provided in this submission shows that the ChemoLock Closed System Drug Transfer Device is able to prevent the egress of chemicals both during preparation and transfer of the cytotoxic agent. Results of the study suggest that the ChemoLock system was effective in preventing detectible surface contamination during three separate trials of compounding activities with known amounts of cyclophosphamide. The prevention of environmental contamination is specifically important for the containment of cytotoxic pharmaceuticals which will passively prevent the exposure to such chemicals by healthcare workers.

The ChemoLock Closed System Drug Transfer Device has been tested in accordance with its performance specification which accommodates known functional requirements.

The ChemoLock Closed System Drug Transfer Device configurations are individually packaged and pre-sterilized in a peel type, Multivac pouch with sealed Tyvek lidding.. The device can be included as part of a closed vial or bag access device, closed syringe adapter, or closed patient administration set. This device may be included as part of a custom kit or set - as prescribed by a physician. ICU Medical performs analysis and design verification testing based on predetermined criteria, which is documented in the Performance Specification contained in this

{3}------------------------------------------------

submission. All testing meets these performance criteria as defined for the device.

ICU Medical has also performed testing that is recommended by the guidance document "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" and successful testing is included as part of this submission in the Extended Use Protocol Results document.

Conclusion:

Performance testing included within this 510(k) demonstrates that the ChemoLock Closed System Drug Transfer Device is safe, effective and performs in an equivalent manner to the predicate devices and in accordance with its intended use.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2013

ICU Medical, Incorporated Ms. Katherine Kenner Regulatory Affairs Specialist 4455 Atherton Drive SALT LAKE CITY UT 84123

Re: K131549

Trade/Device Name: ChemoLock Closed System Drug Transfer Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB, FPA Dated: May 28, 2013 Received: May 29, 2013

Dear Ms. Kenner:

This letter corrects our substantially equivalent letter of July 26, 2013.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Ms. Kenner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Section 4 Indications For Use

Page 1 of 1

510(k) Number (if known): K1315-49

ChamoLock Closed System Drug Transfar Device Device Name:

The ChemoLock Closed System Drug Transfer Device prevents the transfer of Indications for Use: environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓(Per 21 CFR 801.109)	OR	Over-The-Counter Use __
	Richard C. Chapman2013.07.25 09:44:14	(Optional Format 1-2-96)

Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K131549
----------------	---------

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.